Pharmaceutical Law

As lawyers in Wels, we offer comprehensive advice and support in all areas of pharmaceutical law.

Not only the Austrian regulations (in particular the Medicines Act – Arzneimittelgesetz – AMG), but also a number of EU directives and EU regulations are to be observed here.

We advise you inter alia at questions concerning

• Development,
• Production,
• Authorization and distribution of medicines (Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen – BASG) / AGES); MRP (Mutual Recognition Procedure); Decentralized Procedure – DCP; Authorization via the European Medicines Agency in accordance with Regulation (EC) No 726/2004
• Differentiation to medical devices (Medical Devices Act (Medizinproduktegesetz – MPG), Food (nutritional supplements) and cosmetics
• Import of medicines
• Parallel import acc. § 10c Medicines Act (Arzneimittelgesetz) or centrally approved specialty drug according to Regulation (EC) No. 726/2004 – European Medicines Agency (Europäischen Arzneimittelagentur – EMA)
• Generic drugs

We as lawyers in Wels accompany you at

• authorization and registration procedures for proprietary medicinal products,
• the creation of the labeling, the product information and the package information leaflet,
• the application for entry into the Reimbursement Code (Erstattungskodex), as well as
• in regard to the quality assurance.

You will receive advice from our law firm in Wels for your sales and marketing.

Furthermore, as a law firm in Wels we also are at your disposal for advice and preparation of cooperation agreements, in the area of import – export, such as dealer agreements, distribution contracts and agency agreements, confidentiality agreements, terms of purchase, clinical trials, R & D contracts, and other requirements applicable to your business.